Quality of life, decision-making,

costs and the impact on carers

in people managed without dialysis:

A study protocol

Dr Helen Noble

Lecturer – Health Services Research

Queens University Belfast

Northern Ireland

MM. Yaqoob, AP. Maxwell, A. Burns, F. McCourt, A.

Agus, C. McDowell and C. Normand

PACKS PAlliative care in Chronic Kidney Disease Study

Funding - National Institute for Health

Research

Amount - £512,000

Post Doctoral Fellowship in UK

Three years – full time

Aim of study Measure and describe longitudinally, over 12

months, QOL, satisfaction with decision-

making, costs, cognition, frailty and

performance in patients with advanced

chronic kidney disease managed without

dialysis.

Impact on carers will also be studied.

Background Number of people living with end-stage kidney disease

(ESKD) has increased Diabetes (Coresh et al. 2007)

Older people Increasing prevalence of co-morbidities (Ashby et al. 2005)

High mortality - median of five life years remaining for a 70-year

old (Ansell et al. 2009)

For some dialysis may be of little benefit

Provision of treatment for ESKD consumes approx 2%

of annual National Health Service budget (Steencamp et al.

2010)

Stages of renal disease & treatment options

KDOQI CKD classification 2000

Renal Replacement Therapy

Travel times

PD too difficult

Transplant not possible

Arduous

Surgical procedures

Burden

Feel too old (Noble 2009)

Why opt not to dialyse

Primary and secondary outcomes

Primary Outcome: Quality of life of patients at 3

months from baseline measured using the EQ-5D-5L

visual analogue scale.

Secondary outcomes:

Changes in QOL and symptoms (including anxiety and

depression)

Changes in cognition, frailty and performance

Understanding of the decision making process that

precedes referral to CKM

Patient satisfaction with decision-making

Secondary outcomes (cont)

Associated health and social care costs of

patients receiving CKM

Changes in QOL for carers

Care related costs to carers of patients

Calculation of the number(%) of deaths at 3, 6,

9 and 12 months and time to death

Recruitment & sample

Recruited from renal clinics over 7 sites

Patients – 112

Carers – up to 112

Renal physicians/CNS - 15-20

Qualitative interviews

Inclusion criteria patients:

Stage 5 chronic kidney disease

A confirmed decision for conservative

management, i.e. management without dialysis

or other renal replacement therapy. The

decision for conservative kidney management

will be confirmed with the nephrologist

responsible for each patient.

Aged over 18 years.

Able to speak English

Inclusion criteria carers: Primary carer for patient with stage 5

chronic kidney disease who has made a

confirmed decision for conservative kidney

management as agreed with clinicians.

Aged over 18 years.

Patient has agreed that the carer can be

approached to participate.

Able to speak English

Inclusion criteria – renal physicians/CNS

Experience of managing clinical

consultations of patients with stage 5

chronic kidney disease who opt for

conservative kidney management

Employed in the renal specialty

Data collection tools - Patient 3-monthly

Kidney Disease QOL-36™ Survey

EQ-5D-5L

POS-S Renal

6monthly

Decisional Conflict Scale

Ongoing

Patient Service Use Log

Decisional Conflict Scale

Data collection tools - Carer 3-monthly

EQ-5D-5L

EQ-5D-5L by proxy

Carer questionnaire

6monthly

Decisional Conflict Scale

Data collection tools – Renal Physician/CNS

One exploratory qualitative interview with PI

Data collection tools –

performance, frailty, cognition

3-monthly over 12 months

Changes in cognition - 6 Item Cognitive

Impairment Test (6CIT)

Changes in frailty status - 9-point Clinical

Frailty Scale

Changes in Performance using the Palliative

Performance Scale (PPS)

EQ-5D-5L

Standardised instrument for use as a measure of health outcome.

Valid instrument for the measurement of health status in renal

patients.

New 5 level version, EQ-5D-5L

Consists of a descriptive system and a visual analogue scale.

EQ-5D-5L will be self-completed by the patients

Completed for the patient by the carer. Inter-rater agreement can

then be assessed.

(Herdman et al 2011)

EQ-5D-5L

EQ-5D-5L VAS

Development of study

Ethics application and protocol development

Working with Clinical Trials Unit

Site visits to develop protocol

Advisory Team meeting

Return next year!

Thank you for your

attention Helen.noble@QUB.ac.uk

References Ansell D, Castledine C, Feehally J, Fogarty D, Ford D, Inward C, et al. The Renal Association UK Renal Registry.

The Twelfth Annual Report December 2009. Bristol: Renal Registry; 2010 2010/07.

Ashby M, op't Hoog C, Kellehear A, Kerr PG, Brooks D, Nicholls K, et al. Renal dialysis abatement: lessons from a

social study. Palliat Med 2005;19(0269-2163; 5):389-96.

Coresh J, Selvin E, Stevens L. et al. (2007) Prevalence of Chronic Kidney Disease in the United States. JAMA, 298

(17) 2038-2047

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X (2011). Development and

preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 20(10):1727-36.

Noble H, Meyer J, Kelly D et al (2009). Reasons renal patients give for deciding not to dialyse: prospective qualitative

interview study, Dialysis & Transplantation, 38 (3): 82-89.

Steencamp, R., Castledine, C., Feest, T. & Fogarty, D (2010). The Renal Association UK Renal Registry. The

Thirteenth Annual Report December 2010. Available: http://www.renalreg.com/Report-

Area/Report%202010/Chap02_Renal10_web.pdf [Accessed 3.3.14].